Description

Axitinib Impurity B is a specified impurity associated with the active pharmaceutical ingredient Axitinib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Axitinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Axitinib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure compliance with strict pharmacopeial (e.g., USP, EP, ICH) guidelines for impurity limits.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions to determine drug shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Axitinib to minimize the formation of this impurity.

Basic Information

Product Name	Axitinib Impurity B
CAS No.	944835-85-2
Molecular Formula	C22H18N4OS
Molecular Weight	386.47 g/mol
Synonyms	N-Methyl-2-[[3-[(E)-2-pyridin-2-ylethenyl]-1H-indazol-6-yl]sulfanyl]benzamide; Axitinib Related Compound B; Axitinib Impurity 2; AG-013736 Impurity B; (E)-N-Methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)benzamide
EINECS	Contact for details

Quality Control

Our Axitinib Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.